ZUMA-2 was a phase 2, multicenter, international, single-arm, open-label study of patients with R/R MCL1,2

ZUMA-2 trial design including patient population and treatment arms ZUMA-2 trial design including patient population and treatment arms
  • 60 of the 68 patients who were infused were followed for at least 6 months after their first objective disease response and were evaluable in the efficacy analysis1‡
  • Bridging therapy between leukapheresis and lymphodepleting chemotherapy was permitted to control disease burden1,2

Key inclusion criteria2,3

  • One to 5 prior regimens for MCL. Prior therapy must have included all of the following:
    • Anthracycline- or bendamustine-containing chemotherapy
    • Anti-CD20 monoclonal antibody therapy
    • BTKi (ibrutinib or acalabrutinib)
  • At least 1 measurable lesion
  • Age ≥18 years
  • ECOG PS 0 or 1
  • Adequate bone marrow, renal, hepatic, pulmonary, and cardiac functions
  • ALC ≥100 cells/mm3

Key exclusion criteria1,3

  • Previously received allogeneic HSCT, CD19-targeted therapy, or CAR T-cell therapy
  • History of HIV infection or acute or chronic active hepatitis B or C infection. Patients with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing
  • History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement
  • Presence of fungal, bacterial, viral, or other infection that was uncontrolled or required IV antimicrobials for management

*Consisted of cyclophosphamide 500 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously, both given on the fifth, fourth, and third day before TECARTUS.1

TECARTUS was administered to patients as a single intravenous infusion at a dose of 2 × 106 anti-CD19 CAR T cells/kg (maximum permitted dose: 2 × 108 cells).1

Among the 60 efficacy-evaluable patients, 2 x 106 CAR-positive viable T cells/kg were administered to 54 (90%). The remaining 6 (10%) patients received doses of 1.0, 1.6, 1.8, 1.8, 1.9, and 1.9 x 106 CAR-positive viable T cells/kg.1


TECARTUS was studied in a range of patients with R/R MCL—a historically difficult-to-treat population1,4,5

Table showing baseline patient characteristics in all treated patients Table showing baseline patient characteristics in all treated patients

*These data are based on all treated patients (n=68); USPI reports patient characteristics in efficacy-evaluable patients (n=60).1,2

ALC=absolute lymphocyte count; BTKi=Bruton’s tyrosine kinase inhibitor; CAR=chimeric antigen receptor; CNS=central nervous system; DOR=duration of response; ECOG=European Cooperative Oncology Group; HIV=human immunodeficiency virus; HSCT=hematopoietic stem cell transplant; IV=intravenous; MCL=mantle cell lymphoma; MIPI=Mantle Cell Lymphoma International Prognostic Index; ORR=objective response rate; PFS=progression-free survival; PS=performance status; R/R=relapsed or refractory; SCT=stem cell transplant.

References: 1. TECARTUS™ (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2020. 2. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle cell lymphoma. N Engl J Med. 2020;382(14):1331-1342. 3. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle cell lymphoma - supplementary appendix. N Engl J Med. 2020;1-33. 4. Martin P, Maddocks K, Leonard JP, et al. Postibrutinib outcomes in patients with mantle cell lymphoma. Blood. 2016;127(12):1559-1563. 5. Dreyling M, Klapper W, and Rule S. Blastoid and pleomorphic mantle cell lymphoma: still a diagnostic and therapeutic challenge! Blood. 2018;132(26):2722-2729.